Functional package for an anastomosis procedure

ABSTRACT

A system for preparing a graft vessel for anastomosis includes one or more tools held within a functional package having at least one recess. An anastomosis tool or portion thereof may be held in at least one recess. An anastomosis device is connected to the anastomosis tool. At least one recess is shaped and sized to hold an amount of biocompatible fluid sufficient to immerse the anastomosis device.

This application is a continuation of U.S. patent application Ser. No.10/055,179, filed on Jan. 23, 2002, which is incorporated by referencein its entirety.

FIELD OF THE INVENTION

The present invention relates generally to anastomosis, and moreparticularly to a set of tools and a functional package for preparing agraft vessel for anastomosis.

BACKGROUND

Anastomosis is a procedure where two separate tubular or hollow organsare surgically grafted together to form a continuous fluid channelbetween them. Vascular anastomosis involves creating an anastomosisbetween blood vessels to create or restore blood flow. When a patientsuffers from coronary artery disease (CAD), an occlusion or stenosis ina coronary artery restricts blood flow to the heart muscle. In order totreat CAD, the area where the occlusion occurs is bypassed to rerouteblood flow by grafting a vessel in the form of a harvested artery orvein, or a prosthesis. Anastomosis is performed between a graft vesseland two target vessels in order to bypass the blocked coronary artery,circumvent the occlusion and restore adequate blood flow to the heartmuscle. This treatment is known as a coronary artery bypass graftprocedure

In a CABG procedure, a graft vessel such as a saphenous vein, mammaryartery, radial artery or other blood vessel is harvested from thepatient or another source, then placed in a bowl or other container andimmersed in saline, blood or other biocompatible liquid. Before thatgraft vessel is connected to the target vessels, it may be prepared insome way, such as by connecting it to an anastomosis device and/or atool for applying the anastomosis device. The graft vessel is typicallyconnected to the anastomosis device and/or tool manually by one or morepeople in the operating room, using forceps, tweezers and/or othertools. Substantial skill is required to connect the slippery graftvessel to the anastomosis device and/or tool without damaging the graftvessel or otherwise rendering it unusable.

SUMMARY

A system for preparing a graft vessel for anastomosis includes one ormore tools held within a functional package.

In one aspect of the invention, a functional package includes a trayhaving multiple recesses. The package can be sealed, and sterilizedalong with its contents. The recesses are used to hold one or more toolsfor preparing a graft vessel for anastomosis. The tray includes one ormore recesses or other features molded into it that allow for storing agraft vessel in a biocompatible fluid such as blood or saline solution,for moving one or more tools relative to one another, or for performingother functions that would otherwise be handled by additional tools,trays, bowls or other items. Thus, the package reduces waste andoperating room clutter.

In another aspect of the invention, an assembly for receiving a veingraft is held in a recess in the package. The assembly includes a crown,an anastomotic device that is connected to one end of the crown, and anexpander tube within the crown. The crown may be connected to acartridge or other structure. The package holds the crown snugly, whichin turn holds the expander tube. The package holds the assembly while agraft vessel is loaded onto it.

In another aspect of the invention, a pull-through tool includes ahandle connected to a tension member. The handle is held in a recess inthe package, and the tension member is prepositioned within and slidablethrough the crown. At least one grasping element is connected to thetension member. When the tension member is in a first position, at leastone grasping element is configured to receive an end of a graft vessel.When the tension member is moved to a second position, at least onegrasping element is configured to compress or puncture the end of thegraft vessel, thereby holding the graft vessel. The tension member ispulled into one end of the expander and crown, carrying the graft vesselwith it. After a preselected length of the graft vessel has been pulledout of the other end of the crown, the graft vessel is cut to release itfrom the grasping element or elements. The pull-through tool thus allowsfor simple loading of a graft vessel through the crown and expandertubes and onto the anastomotic device.

In another aspect of the invention, a detachable eversion shield is heldin the package, covering at least part of the anastomotic device. Theanastomotic device includes barbs or sharp tips, which are covered bythe eversion shield to provide a substantially continuous smooth surfaceonto which an end of the graft vessel can be everted. The eversionshield is then removed from the crown.

In another aspect of the invention, a poke-through tool is held in arecess in the package. The poke-through tool includes a membrane throughwhich tines or sharp tips of the anastomotic device can penetrate, suchthat contact between the membrane and the end of the graft vessel pushesthe graft vessel down onto the tines to fully engage them, therebypreparing the graft vessel for deployment. A channel in the package maybe configured to receive a portion of the poke-through tool and guidethe travel of the poke-through tool relative to the crown. The channelsubstantially prevents rotation of the poke-through tool during itstranslation relative to the anastomotic device, and is positioned suchthat motion of the poke-through tool along the entire length of thechannel ensures that the poke-through tool has pushed the graft vesselonto the tines of the anastomosis device. Thus, the channel provides forbetter control of the poke-through tool. The poke-through tool also maybe used to release the eversion shield from the anastomosis device.

In another aspect of the invention, the prepared graft vessel isimmersed in a biocompatible fluid, such as saline solution or blood,within a recess in the tray. This may be the same recess in which thecrown, expander tube and anastomosis device were originally held, oranother recess in the tray. The graft vessel is then available for usein an anastomosis tool or other device as needed. By using the packageto immerse and hold the prepared graft vessel, the preparation processis simplified, and the number of fluid containers used is reduced.

In another aspect of the invention, an anastomosis tool is held in arecess in the package. After the graft vessel has been prepared, theassembly is removed from the package and the crown, expander tube andgraft vessel are inserted into an appropriate passage within theanastomosis tool. A removable guide may be held in the integratedanastomosis tool to facilitate insertion of the crown, expander tube andgraft vessel, and is removed after the anastomosis tool has received atleast a portion of the crown, expander tube and graft vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an expanded view of the components of a functional package.

FIG. 2 is a perspective view of a tray that is a component of thefunctional package of FIG. 1.

FIG. 3 is a perspective view of the tray of FIG. 2 in which apull-through tool is held in a recess in the tray.

FIG. 4 is a perspective view of an outer shell that is a component ofthe functional package of FIG. 1.

FIG. 5 is a perspective view of the pull-through tool.

FIG. 6 is a top view of the pull-through tool.

FIG. 7 is a perspective view of the tray of FIG. 2 in which a number ofcomponents are held.

FIG. 8 is a side view of an assembly including a crown and ananastomosis device.

FIG. 9 is a top view of a stop clip that is detachably connectable tothe tray.

FIG. 10 is a side cross-section view of the stop clip of FIG. 9.

FIG. 11 is a perspective view of an eversion shield.

FIG. 12 is a different perspective view of the eversion shield of FIG.11.

FIG. 13 is a perspective view of an alternate eversion shield.

FIG. 14 is a perspective view of the eversion shield of FIG. 13 coveringan anastomosis device.

FIG. 15 is a perspective view of the eversion shield of FIG. 13illustrating the eversion of a graft vessel over the eversion shield.

FIG. 16 is a cutaway exploded view of the poke-through tool.

FIG. 17 is a side view of the poke-through tool.

FIG. 18 is a perspective view of the graft vessel relative to theanastomosis device after the poke-through tool has pushed the graftvessel through the tines of the anastomosis device.

FIG. 19 is a perspective view of the eversion shield of FIG. 13 afterthe poke-through tool has split it for removal.

FIG. 20 is a perspective view of an anastomosis tool and a guide usedtherewith.

FIG. 21 is a perspective view of the guide of FIG. 20.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

Referring to FIG. 1, a functional package 2 for preparing a graft vesselfor anastomosis is shown. The system includes a tray 4, a tray top 6, anouter shell 8, a cover 10 and an exterior box 12. Referring also toFIGS. 2-3, the tray 4 is shown in greater detail. The tray 4 isconstructed from vacuum-formed plastic or other biocompatible material.The tray 4 need not be vacuum-formed, and may be constructed in adifferent way if desired. A lip 24 extends outward at least partlyaround the perimeter of the tray 4. The lip 24 is substantiallyhorizontal. Alternately, the lip 24 may be oriented differently in wholeor in part. For example, the lip 24 may be angled relative to thehorizontal. Alternately, two or more separate lips 24 are provided alongportions of the perimeter of the tray 4. The lip 24 extends outward froma ledge 26 that extends at least partly around the perimeter of the tray4. The ledge 26 extends substantially vertically. Alternately, the ledge26 may be oriented differently in whole or in part. For example, theledge 26 may be angled relative to the vertical. Alternately, two ormore separate ledges 26 are provided along portions of the perimeter ofthe tray 4. The ledges 26 extend downward to a surface 27 that issubstantially horizontal. The surface 27 may be oriented differently, ifdesired. A number of recesses are formed into the tray 4, recessedrelative to the surface 27. These recesses may be molded into the tray4, or formed in another way. These recesses may include a working recess28, a poke-through tool recess 30, an anastomosis tool recess 32, and astabilizing recess 34. The functions of the recesses 28, 30, 32, 34 aredescribed in greater detail below.

Referring back to FIG. 1, the tray top 6 rests on the tray 4, and may besealed to it. One or more features 40 are formed into the tray top 6 toprovide clearance for tools held in the tray 4. The features 40 may bemolded into the tray top 6 or otherwise formed into the tray top 6. Thetray top 6 assists in restraining the tools held in the tray andprotecting them from contamination. One or more lips 36 extend outwardfrom the perimeter of the tray top 6. The lip 36 of the tray top 6 isconstructed to correspond with the lip 24 of the tray. Thus, if the lip24 of the tray 4 is substantially horizontal, then the lip 36 of thetray top 6 is substantially horizontal. When the tray top 6 is placed onthe tray 4, the lip 36 of the tray top 6 contacts the lip 24 of the tray4.

Referring also to FIG. 4, the outer shell 8 is substantiallyrectangular, and a protrusion 36 is provided at or near each corner ofthe outer shell 8. Alternately, the outer shell 8 is shaped differently.Alternately, the protrusions 36 may be located in less than all cornersof the outer shell 8, or in different positions in the outer shell 8.The protrusions 36 extend into an open space within the outer shell 8.Each protrusion 36 includes a depression 37 shaped to correspond to theshape of the lip 24 at each corresponding corner of the tray 4. The lip24 of the tray 4 rests on one or more of the depressions 37. By holdingthe tray 4 at each of its corners, the tray 4 is supported andstabilized relative to the outer shell 8. The depressions 37substantially prevent lateral motion of the lip 24 of the tray 4relative to the outer shell 8. Alternately, the tray 4 may be held moresecurely at one or more of the depressions 37, such as by the use ofclips, friction fitting, adhesive, or other structures, mechanisms ormethods. Alternately, other or additional features may be provided inthe inner surface of the outer shell 8 to hold the tray 4. The lip 36 ofthe tray top 6 is placed on the lip 24 of the tray 4, and is held inplace by the depressions 37 in the same manner as the lip 24 of the tray4. The depressions 37 are sized to receive and hold both lips 24, 36.

One or more ridges 38 may be defined in the outer shell 8 in addition tothe protrusions 36. If so, the lip 24 of the tray 4 may rest on theridge or ridges 38 as well. Optionally, dimples (not shown) may beprovided in a wall 41 of the outer shell 8 above the ridge or ridges 38.The lower surface of each dimple is positioned above a correspondingridge 38 a distance substantially equal to the thickness of the lip 24of the tray 4, in order to retain the tray 4 more securely within theouter shell 8. Thus, the tray 4 is snapped into place in the outer shell8 over the dimples. Alternately, each dimple is positioned above acorresponding ridge 38 a distance substantially equal to the combinedthickness of the lip 24 of the tray 4 and the lip 36 of the tray top 6,in order to retain both the tray 4 and the tray top 6 more securely.

The cover 10 is bonded to the outer shell 8, such that the cover 10seals the interior of the outer shell 8. The outer shell 8 may include alip 43 extending outward from its perimeter, such that the cover 10 issealed to the surface of the lip 43. The cover 10 may be fabricated outof TYVEK® brand protective material, a breathable, paper-thin materialfabricated from olefin fibers. A different material capable of sealingthe outer shell 8 may be used instead. The cover 10 is sealed to theouter shell 8 in such a way as to allow sterility to be maintainedwithin the outer shell 8. Thus, the combination of the outer shell 8 andthe cover 10 protect the tray 4 and tray top 6, allow them and the toolsheld within them to be sterilized and to remain sterile during storage,and provide a sterile interior even when the outer shell 8 is placed ona non-sterile surface.

The outer shell 8 and cover 10 may be placed in the exterior box 12. Theexterior box 12 protects the outer shell 8 and cover 10 from outsideelements during storage and during transportation to the surgerylocation. The exterior box 12 may be constructed from any material. Theentire functional package 2 and its contents are sterilizable throughthe exterior box 12.

To begin preparation of a graft vessel for anastomosis, the exterior box12 is opened, and the outer shell 8 and the cover 10 are slid out of it.The outer shell 8 is placed upon a table or other surface in anoperating room. The cover 10 is then removed from the outer shell 8. Thetray 4 and tray top 6 then may be moved into the sterile field and theexterior box 12 and the cover 10 may be discarded. The tray top 6 isthen removed and set aside or discarded, and the tray 4 is moved to asurgical table or other area near the patient. The tray 4 and the toolswithin are then exposed and available for use.

The tray 4 is placed on a substantially flat surface such as a tabletop.The recesses 28, 30, 32 are shaped and positioned such that they rest onthat substantially flat surface. When saline solution, blood or otherbiocompatible fluid is introduced into those recesses 28, 30, 32, theweight of that fluid holds the tray 4 against that surface. One or morestabilizing recesses 34 additionally may be provided in the tray 4. Thestabilizing recesses 34 receive saline solution or other biocompatiblefluid as well, such that the weight of that fluid holds the stabilizingrecess 34 down and provides additional stability to the tray 4.Alternately, one or more of the recesses 28, 30, 32 do not contact thesurface on which the tray 4 is placed. Alternately, none of the recesses28, 30, 32 contact the surface on which the tray 4 is placed, and thetray 4 is stabilized solely by the use of stabilizing recesses 34. Agraft vessel storage recess 42 optionally may be provided in the tray 4.Biocompatible fluid such as blood or saline is placed in the graftvessel storage recess 42, and the graft vessel for use in theanastomosis procedure is placed in that fluid in the graft vesselstorage recess 42 until the appropriate time for preparing it.Alternately, where at least one stabilizing recess 34 is provided, astabilizing recess 34 is used for storing the graft vessel before itspreparation.

Referring to FIGS. 3, 5 and 6, a pull-through tool 44 rests within theworking recess 28 before it is used. The pull-through tool 44 may beinterference-fit to the working recess 28 to substantially prevent itsmovement relative to the tray 4. Alternately, the pull-through tool 44is loosely fit within the working recess 28. Alternately, the tray top 6is shaped to restrain the pull-through tool 44 within the working recess28.

The pull-through tool 44 includes a handle 48 connected to a tube 50,through which at least one tension member 52 extends. The handle 48includes two flexible members 54. The members 54 are connected to oneanother, directly or indirectly, at the proximal end and the distal endof the handle 48. The members 54 may be connected to one another atdifferent or at additional locations. The flexibility of each member 54of the handle 48 may be provided by one or more living hinges 56 thatconnect segments 57 of each member 54. Each segment 57 may be a thin,substantially rectangular structure. Alternately, the segments 57 may beshaped differently. The handle 48 is injection-molded plastic, such thatthe living hinges 56 are sufficiently strong and flexible to allow themembers 54 to flex. The handle 48 may be constructed in a differentmanner or from a different material, if desired. Alternately, the handle48 may be constructed from a compliant material, or made flexible inanother manner. One or more segments 57 may include a grip 55 configuredto be held by an operator. Each grip 55 is a structure curved to fit ahuman finger or thumb. Alternately, the grips 55 may be shapeddifferently.

The distal end of the handle 48 includes a collar 58 connected to andcoaxial with the tube 50. Alternately, the collar 58 is located at aposition on the handle other than its distal end. The members 54 may beconnected to each other at their distal ends through connection with thecollar 58. The tube 50 is also hollow, having a lumen therethrough. Alumen extends through the tube 50 and the collar 58. Alternately, thecollar 58 is not used, and a hole or other passage is defined throughthe distal end of the handle 48 at or near the distal intersection ofthe members 54. The tube 50 is fixed to the collar 58. Alternately, thetube 50 is moveable relative to the handle 48. The tube 50 isconstructed from a substantially flexible biocompatible material, suchas polyethylene. Alternately, the tube 50 is not substantially flexible.

The handle 48 also includes a first arm 70 and a second arm 72, eachconnected to a different member 54. The arms 70, 72 are positionedrelative to one another such that compression of the handle 48 movesthem closer together. The first arm 70 is connected to one member 54 ofthe handle 48. The first arm 70 includes a ratchet pawl 74 at one endand a release element 76 on its surface. The ratchet pawl 74 and/or therelease element 76 may be provided on other portions of the first arm70, if desired. The ratchet pawl 74 is a wedge configured to mate with acorresponding element on the second arm 72, as described below. Theratchet pawl 74 may take another shape, if desired. The release element76 is a protrusion or other structure connected to or formed into thefirst arm 70 in a direction substantially perpendicular to the first arm70. The release element 76 may have a different angle relative to thefirst arm 70, if desired. The first arm 70 is configured to flex in adirection substantially perpendicular to the first arm 70, or in adifferent direction. The second arm 72 is connected to the other member54. The second arm 72 includes one or more recesses 78 into which theratchet pawl 74 of the first arm 70 can be received. The recesses 78 areprovided on the underside of the second arm 72. Alternately, therecesses 78 are provided on a different surface of the second arm 72. Achannel 79 extends substantially through the center of the second arm72, providing a space through which the release element 76 can pass whenthe handle 48 is compressed. Alternately, the channel 79 is offsetwithin the second arm 72. The recesses 78 are located on both sides ofthe channel 79, such that the ratchet pawl 74 can engage recesses 78 onboth sides of the channel 79. Alternately, the channel 79 is notprovided, where the release element 76 has a different configuration oris not used, or where the arms 70, 72 are configured differently.

Two tension members 52 are utilized. Alternately, a single tensionmember 52 is provided, having a split distal end including two or moregrasping elements 60. Alternately, three or more tension members 52 maybe used. Each tension member 52 is a wire constructed from stainlesssteel or other biocompatible material. Alternately, each tension member52 may be constructed from a different material, or take a form otherthan a wire, such as a loop. The tension members 52 extend through thelumen of the tube 50. The proximal end of each tension member 52 isconnected to the proximal end of the handle 48. The proximal end of thehandle 48 may include a stud 66 to which the proximal end of eachtension member 52 is fixed. More than one stud 66 may be provided, suchthat each tension member 52 is connected to a separate stud 66. Thedistal end of each tension member 52 extends out of the distal end ofthe tube 50. The distal ends of the tension members 52 are angledrelative to the axis of the tube 50. A grasping element 60 is located atthe distal end of each tension member 52. Alternately, the graspingelement 60 is connected to a different location on the tension member52. The distal end of each tension member 52 is bent to form thegrasping element 60. A separate grasping element 60 may instead beconnected to the distal end of each tension member 52. The graspingelement 60 of each tension member 52 is oriented inward, toward the axisof the tube 50. Alternately, the grasping element 60 may be oriented atleast partly in a different direction. One or more positioners 80 may beincluded on or connected to the tension members 52, each contacting andslidable relative to the inner surface of the tube 50, to facilitatemotion of the tension members 52 through the tube 50.

Referring also to FIGS. 7-8, an assembly 94 includes a cartridge 62, acrown 96, and an anastomosis device 98. An expander tube (not shown) isalso included in the assembly 94, and is located partly within andcoaxial with the crown 96, and partly within and coaxial with theanastomosis device 98. The crown 96 is a tube having two ends. One endof the crown 96 is slidably connected to the cartridge 62. The cartridge62 is a component of an anastomosis tool 64 that is held in theanastomosis tool recess 32 of the tray 4. The cartridge 62 and the crown96 may be a single piece that is molded or otherwise formed together.The crown 96 may extend through the entire cartridge 62, through part ofthe cartridge 62, or none of the cartridge 62. The cartridge 62 includesa lumen defined therethrough to receive the crown 96, the expander tube,and the tube 50 of the pull-through tool 44. The anastomosis device 98is connected to the other end of the crown 96. This connection may bemade by any structure, mechanism or method. The assembly 94 is held in aportion of the working recess 28. Alternately, a separate recess may beprovided for the assembly 94. The assembly 94 may be friction-fit to theworking recess 28 to substantially prevent its movement relative to thetray 4. Alternately, the assembly 94 is loosely fit within the workingrecess 28. Alternately, the tray top 6 is shaped to restrain theassembly 94 within the working recess 28. The assembly 94 is held in thetray 4 such that the tube 50 of the pull-through tool 44 extends intothe expander tube within the crown 96 and out of the end of thecartridge 62 opposite to the crown 96. The working recess 28 is shapedto align the pull-through tool 44 and the assembly 94 such that the tube50 can extend into the expander tube within the crown 96 while both areheld in the tray 4.

Referring to FIGS. 7-10, a stop clip 82 is detachably connected to thetray 4. The stop clip 82 is pressure-fit into a depression 84 in thetray 4. However, the stop clip 82 may be connected to the tray 4 inanother way. As one example, the stop clip 82 may be fixed to the tray4, as with adhesive, or by molding the stop clip 82 and the tray 4 as aunit. The stop clip 82 includes a flange 86 that is fit against thesurface of the tray 4 when the stop clip 82 is connected to the tray 4.The flange 86 may be omitted, if desired. The stop clip 82 includes aguide 88 that is wide enough to receive the tube 50 of the pull-throughtool 44. The tube 50 may extend within the guide 88 while thepull-through tool 44 is held in the tray 4. Alternately, the guide 88 isabove the tube 50 while the pull-through tool 44 is held in the tray 4.The guide 88 is sloped upward in the direction toward the handle 48 ofthe pull-through tool 44, and may widen in that direction as well. Thestop clip 82 may also include two depressions 90, one on each side ofthe guide 88, where the guide 88 extends upward relative to the bottomsurface of each depression 90.

The pull-through tool 44 is moveable between a neutral configuration, inwhich the grasping elements 60 are separated from one another to receivea graft vessel, and an engaged configuration, in which the graspingelements 60 have moved together to engage the graft vessel. Initially,the pull-through tool 44 is in the neutral configuration as shown inFIG. 5. To operate the pull-through tool 44, a graft vessel 92 isremoved from the graft vessel storage recess 42 of the tray 4 orotherwise obtained. The graft vessel 92 may be a vein graft such as asaphenous vein or a radial artery, as commonly used during a CABGprocedure. However, the graft vessel 92 may be a tubular vessel otherthan one from the vasculature, and may be used in a surgery other than aCABG procedure. Advantageously, the end of the graft vessel 92 to beengaged by the pull-through tool 44 is cut at an angle on two oppositesides, in order to taper the graft vessel and facilitate its passagethrough the crown 96. The end of the graft vessel 92 may instead be cutsubstantially to its axis, or may not be cut at all. That end of thegraft vessel 92 is held between the vein-grabbing elements 60 of thetension members 52 with forceps, by hand, or with a different tool. Theoperator of the pull-through tool 44 then begins to squeeze the handle48. As the handle 48 is squeezed, the arms 70, 72 approach one another.Additionally, as the handle 48 is squeezed, the members 54 of the handlemove closer to one another, and the length of the handle 48 increases.The proximal end of each tension member 52 is fixed to the proximal endof the handle 48, and the tension members 52 are slidable relative tothe tube 50. As a result, the proximal end of the handle 48 pulls thetension members 52 proximally relative to the collar 58. Because thetube 50 is fixed to the collar 58, the tension members 52 thus moveproximally relative to the tube 50 as well. The distal ends of thetension members 52 are angled relative to the axis of the tube 50. Thus,as the tension members 52 move proximally, they move into the tube 50,and contact between the angled distal ends of the tension members 52 andthe tube 50 causes the tension members 52 to move closer to one another.Consequently, the grasping elements 60 move closer to one another.

Referring as well to FIG. 5A, as the handle 48 continues to be squeezed,the distance between the grasping elements 60 continues to decrease, andthey engage the graft vessel 92 by penetrating it. Alternately, thegrasping elements 60 may be configured to capture the graft vessel 92without piercing or penetrating it. The arms 70, 72 are configured suchthat the ratchet pawl 74 of the first arm 70 encounters at least onerecess 78 of the second arm 72 after the grasping elements 60 have movedto a position in which they are holding the graft vessel 92. Therecesses 78 may be downwardly-extending spaces between teeth, or may beshaped differently. The first arm 70 is moveable in a directionperpendicular to its direction of motion toward the second arm 72, suchthat the ratchet pawl 74 can be deflected downward as the ratchet pawl74 moves toward a recess 78, then deflect upward into a recess 78. Thefirst arm 70 is configured to bias the ratchet pawl 74 into the recess78 to secure the ratchet pawl 74 and recess 78 together when thegrasping elements 60 have engaged the graft vessel. Recesses 78 may beprovided at different distances from the first arm 70, such that thehandle 48 can lock into a selected one of a number of differentpositions.

The graft vessel 92 is thus firmly held by the grasping elements 60 ofthe pull-through tool 44. The user then begins to pull the handle 48 ofthe pull-through tool 44 in a direction away from the assembly 94. Inthis way, the pull-through tool 44 begins to pull the graft vessel 92through the lumen of the cartridge 62 and the crown 96. In order to pullthe pull-through tool 44 in this direction, the handle 48 is lifted outof the working recess 28. The guide 88 of the stop clip 82 is shaped toallow the handle 48 to be moved away from the axis of the crown 96, andto control the motion of the tube 50 through the crown 96 to besubstantially coaxial with the axis of the crown 96. The tube 50 isflexible, such that it bends based on its contact with the guide 88. Thehandle 48 continues to be moved away from the cartridge 62 until aportion of the graft vessel 92 is pulled out of the crown 96 adjacent tothe anastomosis device 98 far enough to allow it to be cut with ascissors, scalpel or other tool. This cut is made between theanastomosis device 98 and the grasping members 60, thereby freeing thegraft vessel 92 from the pull-through tool 44. The pull-through tool 44and the portion of the graft vessel 92 retained by the grasping members60 may then be discarded.

The release element 76 on the first arm 70 of the handle 48 can be usedat any time during the operation of the pull-through tool 44 to releasethe graft vessel 92. By pressing on the release element 76, the firstarm 70 is moved out of engagement with the recesses 78 of the second arm72. The direction in which the release element 76 is pressed issubstantially opposite to the direction in which the first arm 70 isbiased. The handle 48 is then free to move back to its original, neutralconfiguration. Consequently, the tension members 52 move distallyrelative to the handle 48, and the grasping elements 60 once again moveapart from one another, freeing the graft vessel 92. As an example ofthe use of the release element 76, an operator may utilize the releaseelement 76 to free the graft vessel 92 if he or she is not satisfiedwith the security with which the grasping elements 60 have engaged thegraft vessel 92.

The anastomosis device 98 is positioned at one end of the crown 96.Referring to FIGS. 7 and 11-12, the anastomosis device 98 may includeone or more tines 99 extending outward from it, at least partially inthe direction of the axis of the crown 96. One or more tines 99 mayextend in a different direction, if desired. An eversion shield 100 isplaced over the anastomosis device 98, covering at least one of thetines 99, to facilitate eversion of the graft vessel 92. The eversionshield 100 is optional. If the eversion shield 100 is not used, thegraft vessel 92 is everted over the anastomosis device 98 directly. Theeversion shield 100 includes a substantially tubular body 102. The body102 instead may be shaped differently. A barrier 104 is located at oneend of the body 102. The barrier 104 is substantially tubular as well.The barrier 104 substantially encircles the tines 99 on the anastomosisdevice 98 and may contact them in whole or in part. The barrier 104 alsoextends further in the axial direction than the tines 99. Thus, thebarrier 104 substantially covers the tines 99. The surface of thebarrier 104 is substantially smooth, and the end of the barrier 104 issmoothed and/or finished to ensure that contact between the barrier 104and the graft vessel 92 does not damage the graft vessel. The barrier104 is open, allowing passage of the graft vessel 92 through it. Thetines 99 are positioned in front of the anastomosis device 98. Thus, thebarrier 104 may have a different diameter than the body 102 or taper toa narrower dimension than the body 102 in order to contact and cover thetines 99. Alternately, the barrier 104 may have substantially the samediameter as the body 102, depending on the configuration of theanastomosis device 98.

One or more slots 106 are positioned between the barrier 104 and thebody 102. The slots 106 extend in a direction substantially parallel tothe axis of the body 102, and are cut through the eversion shield 100.Alternately, the slots 106 do not extend entirely through the eversionshield 100. Alternately, the slots 106 extend in a different direction.The end of the body 102 opposite the barrier 104 may be connected to asecondary body 108 that is wider than the body 102. The secondary body108 instead may be formed into the body 102. A tab 110 is connected tothe secondary body 108 at or near the end of the secondary body 108opposite from the body 102. Alternately, the tab 110 may be connected toanother portion of the secondary body 108 or to the body 102, as long asits position does not interfere with the eversion of the graft vessel92. The tab 110 is sized to be graspable by a user. The tab 110 mayinclude ribs 112 or other features to enhance the use's grip upon thetab 110.

As another example of an eversion shield 100, referring to FIGS. 13-15,at one end of the eversion shield 100 the barrier 104 is positioned tocover at least one of the tines 99, as described above. The eversionshield 100 includes a body 102 connected to the barrier 104. The body102 is substantially tubular, but may be shaped differently if desired.One or more slots 106 are cut through the body 102 in a directionsubstantially parallel to the axis of the body 102. The slots 106 may becut in a different direction, if desired. At the end of the body 102opposite from the barrier 104 is a stop 116. The slots 106 extendsubstantially as far as the stop 116. Alternately, the slots 106 do notextend as far as the stop 116. The stop 116 is a ring having a diameterlarger than the diameter of the body 102. The stop 116 instead may beshaped differently.

Referring particularly to FIG. 15, a person utilizes one or more forceps118 or other tools to evert the end of the graft vessel 92 over thebarrier 104. Two or more people may work together to perform theeversion, if desired. The graft vessel 92 is everted across the singlesubstantially smooth end of the barrier 104 and onto the outer surfaceof the barrier 104. Eversion over the smooth end and surface of thebarrier 104 is simpler than eversion over one or more tines 99. Further,the amount of eversion can be adjusted after the end of the graft vesselhas been everted over the barrier 104, because the graft vessel 92 canslide over the smooth end of the barrier 104 without being damaged.

After the graft vessel 92 has been everted over the barrier 104, theeversion shield 100 is removed and the tines 99 are poked through thegraft vessel 92. Referring to FIG. 7, a poke-through tool 120 is held inthe poke-through tool recess 30. Referring also to FIGS. 16-17, thepoke-through tool 120 includes three primary components: a shell 122, amembrane 126, and a tensioning member 160. The shell 122 has an opening124 at one end that is large enough to be slid over the anastomosisdevice 98. The shell 122 includes a shoulder 125, where the diameter ofthe shell 122 increases from a first diameter to a second, largerdiameter. The first diameter of the shell 122 is near the opening 124,and the second diameter is further from the opening 124. The shell 122may be shaped differently, such that the shoulder 125 is present at thelocation at which the area enclosed by a perpendicular cross-section ofthe shell 122 increases. A membrane 126 is connected to the shell 122 atthe shoulder 125. The membrane 126 is made of polyester film, and issubstantially 1 mil (0.001) inches thick. However, the membrane 126 maybe made of any other appropriate material or combination of materials,and/or have a different thickness.

The tensioning member 160 includes a drum 174 connected by springmembers 176 to a base 178. The drum 174 is sized and shaped to contactthe membrane 126, tension it, and hold it in place. The shoulder 125includes a substantially circumferential groove 162 defined therein.Alternately, the groove 162 may extend in a different direction, ormultiple, smaller grooves or notches may be used. A ridge 164 is definedat the end of the drum 174 that contacts the membrane 126. The ridge 164is shaped and sized to correspond to the groove 162, such that axialforce applied to the tensioning member 160 causes the ridge 164 to pressa portion of the membrane 126 into the groove 162, holding it in placeand tensioning it. Thus, the membrane 126 is substantially flat wherethe tines 99 contact it. A post 166 is located substantially at theaxial centerline of the tensioning member 160, at the end of the drum174 that contacts the membrane 126. A trough 168 at least partiallysurrounds the post 166.

One or more flexures 170 are provided on the base 178 of the tensioningmember 160, configured to engage mating structures 172 defined in theshell 122. Such engagement connects the tensioning member 160 to theshell 122, and axially compresses the spring members 176. This axialcompression acts against the membrane 126 and the shoulder 125 to holdthe membrane 126 in place and tension it. Other structures, mechanismsor methods than flexures 170 may be used to connect the tensioningmember 160 to the shell 122. Further, other structures, mechanisms ormethods may be used to exert a substantially axial force on the membrane126 to hold it in position and to tension it.

The poke-through tool 120 also includes one or more sliders 128extending from the shell 122. Referring also to FIG. 3, the sliders 128are sized to fit into and slide within a channel 130 located in theworking recess 28. The channel 130 is a substantially rectangulardepression having a substantially rectangular cross-section in theworking recess 28. Alternately, the channel 130 may have a differentshape or cross-section. The channel 130 has a centerline that issubstantially parallel to the axis of the crown 96. The sliders 128 aresized to place the shell 122 substantially coaxial with the crown 96.Thus, motion of the poke-through tool 120 along the channel 130 causesthe shell 122 to move substantially coaxially relative to the crown 96.The sliders 128 are curved structures extending from the shell 122,shaped to substantially prevent lateral movement or angular movement ofthe poke-through tool 120 relative to the axis of the crown 96.Alternately, one slider 128 is used, having a substantially rectangularshape substantially as wide as the channel 130. Alternately, the slideror sliders 128 have a different shape. Any shape or number of sliders128 may be used that substantially prevent lateral movement or angularmovement of the poke-through tool 120 relative to the axis of the crown96.

In operation, the poke-through tool 120 is removed from the poke-throughtool recess 30. The sliders 128 of the poke-through tool 120 are placedin the channel 130 in the working recess 28, with the opening 124 of theshell 122 facing the anastomosis device 98. The poke-through tool 120 isthen slid toward the anastomosis device 98 along the channel 130. Theshape of the channel 130 and its contact with the sliders 128substantially prevents rotation of the poke-through tool 120 during itstranslation relative to the anastomotic device 98. As the poke-throughtool 120 moves toward the anastomosis device 98, the anastomosis device98 enters the opening 124 in the shell 122. The graft vessel 92 has beeneverted over the anastomosis device 98, as described above. The membrane126 contacts the everted graft vessel 92 at a point in the translationof the poke-through tool 120. The motion of the membrane 126 forces thegraft vessel 92 onto the tines 99, causing the tines to poke through thegraft vessel 92. The tips of the tines 99 then contact the membrane 126,penetrating it and entering the trough 168. This penetration may make asound, providing auditory confirmation that the tines 99 have piercedthe membrane 126. The post 166 supports the membrane 126 against theforces that result from contact between the tines 99 and the membrane126. The poke-through tool 120 continues to translate in the samedirection, such that the membrane 126 pushes the graft vessel 92 downonto the tines 99 of the anastomosis device 98. The channel 130 is sizedand positioned such that motion of the poke-through tool 120 along theentire length of the channel ensures that the poke-through tool 120 haspushed the graft vessel onto the tines 99 a preselected amount. That is,the length of the channel 130 controls the amount of translation of thepoke-through tool 120. The poke-through tool 120 is then moved in theopposite direction along the channel 130, away from the anastomosisdevice 98. The end result is shown in FIG. 18, where the graft vessel 92has been pushed down onto the tines 99.

Referring also to FIGS. 11-12, if the eversion shield 100 is used, thepoke-through tool 120 also cooperates with the eversion shield 100 torelease the eversion shield 100 from the crown 96 and/or anastomosisdevice 98. As the poke-through tool 120 moves relative to the crown 96,a portion of the poke-through tool 120 contacts the shoulder 107 betweenthe body 102 and the secondary body 108 of the eversion shield 100.Because the barrier 104 has a smaller diameter than the shoulder 107,the eversion shield 100 resists motion in the direction of the motion ofthe poke-through tool 120. Additionally, the poke-through tool 120 maystress the shoulder 107 via direct contact. Further attempted motion ofthe poke-through tool 120 relative to the eversion shield 100 in thesame direction thus results in a force on the eversion shield 100. Thisforce results in stress within the eversion shield 100. This stress actsto extend the slots 106 in the direction toward the poke-through tool120 and split one end of each slot 106 open relative to the end of theeversion shield 100 nearest the poke-through tool 120. The shape of theslots 106 and the thickness and composition of the body 102 are selectedto result in such splitting upon this stress. After the slots 106 havesplit open, the width of the barrier 104 is no longer a constraint onthe motion of the eversion shield 100, which is free to move relative tothe crown 96, away from the anastomotic device 98. Referring to FIG. 12,the eversion shield 100 includes a split 109 on one surface to allow itto be removed from the crown 96 entirely. The split 109 extends alongthe body 102 and secondary body 108 of the eversion shield 100, suchthat the body 102 and secondary body 108 can flex as the eversion shield100 is pulled from the crown 96 in a direction substantiallyperpendicular to the axis of the crown 96.

Similarly, the poke-through tool 120 also cooperates with the eversionshield 100 as shown in FIGS. 13-15. The poke-through tool 120 encountersthe stop 116 as the poke-through tool 120 is moved toward theanastomosis device 98. Because the barrier 104 has a smaller diameterthan the anastomotic device 98 and the crown 96, the eversion shield 100resists motion in the direction of the motion of the poke-through tool.120. Further attempted motion of the poke-through tool 120 relative tothe eversion shield 100 in the same direction thus results in a force onthe eversion shield 100. This force results in stress within theeversion shield 100. Referring also to FIG. 19, this stress acts toextend the slots 106 in the direction toward the poke-through tool 120and split one end of each slot 106 open relative to the end of theeversion shield 100 nearest the poke-through tool 120. The shape of theslots 106 and the thickness and composition of the eversion shield 100are selected to result in such splitting upon this stress. Further, theshape of the slots 106 is chosen such that fracturing and tearpropagation begins at the end 115 of each slot 106. After the slots 106have split open, the width of the barrier 104 is no longer a constrainton the motion of the eversion shield 100. The freed eversion shield 100is then pushed behind the everted portion of the graft vessel 92, awayfrom the anastomotic device 98, such that individual elements 117 formedby the fracturing of the eversion shield 100 splay outward at an angleto the axis of the eversion shield 100. The eversion shield 100 can thusbe safely slid forward over the everted portion of the graft vessel 92,and removed from the crown 96. Alternately, the eversion shield 100 maybe constructed to be removable from the anastomotic device 98 and/or thecrown 94 without contacting the poke-through tool 120. Alternately, atool other than the poke-through tool 120 may be used to remove theeversion shield 100 from the anastomotic device 98 and/or the crown 94.

The graft vessel 92 is then ready for an anastomotic procedure. Thepull-through recess 28 is filled with saline or other biocompatiblefluid to a depth such that the prepared graft vessel 92 held on theassembly 94 is substantially immersed in that fluid until needed. Thus,the graft vessel 92 can be prepared before or while a surgeon or othermedical professional prepares the patient and/or performs other taskspreparatory to the anastomotic surgery. In this way, the tray 4 not onlyholds a number of tools 44, 100, 120 used for preparing the graft vessel92, but also provides a sterile retaining area in which the graft vessel92 can be immersed after being prepared. The working recess 28 is deepenough to hold biocompatible fluid up to a level covering the crown 96and the prepared graft vessel 92. When the crown 96 is covered withfluid, the expander tube within is located below the fluid level aswell. Thus, the assembly 94 is held within the working recess 48 whileone or more tools, such as the pull-through tool 44 and the poke-throughtool 120, are moved relative to and/or interface with the assembly 94 inorder to prepare the graft vessel 92. The assembly 94 and the attachedgraft vessel 92 are held within the working recess 48 until the surgeonis ready to perform anastomosis.

When the surgeon is ready to perform anastomosis, the assembly 94 isremoved from the biocompatible fluid within the working recess 28 andconnected to the anastomosis tool 64. Referring to FIG. 20, theanastomosis tool 64 includes a passage 132 therethrough with a diameterlarge enough to receive the crown 96, expander tube, anastomosis device98 and graft vessel 92. The anastomosis tool 64 includes at least oneedge 136 for mating with the cartridge 62, and may include one or moreflanges 138. A clip 134 is connected to and detachable from theanastomosis tool 64. The clip 134 includes an indented feature 139configured to fit onto the edge 136. This fit may be a pressure fit.Alternately, the clip 134 is connected to the edge 136 and/or at leastone flange 138, or to another portion of the anastomosis tool 64, in adifferent way. Alternately, the indented feature 139 may be configuredto fit onto a different structure on the anastomosis tool 64.

The clip 134 includes tabs 140, 142 configured to fit onto one of theflanges 138. Two tabs 140 fit over the flange 138, and one tab 142 fitsunder the flange 138. Structures other than or in addition to the tabs140, 142 may be used to connect the clip 134 to at least one flange 138and/or to another structure. A stop 141 extends upward from the proximaltab 140. The clip 134 includes a paddle 148 extending away from theanastomosis tool 64. The paddle 148 includes a grip feature 144 that anoperator can grasp or otherwise engage. The paddle 148 may be anindentation, hole, or other feature. The paddle 148 may also include apassage 146 through which a strap or other retainer (not shown) may beinserted, in order to reduce the parts count. Alternately, the passage146 is not used, and the strap or other retainer passes through the gripfeature 144.

The clip 134 includes a platform 150 that extends between the indentedfeature 139 and the tabs 140, 142. The platform 150 includes anindentation 152. The indentation 152 has an arcuate cross-section thatis aligned with the passage 132 in the anastomotic tool 64. Theindentation 152 is shaped to guide the crown 96 into the passage 132.Thus, the indentation 152 is shaped to have a radius of curvaturesimilar to the crown 96. Alternately, the indentation 152 may have adifferent shape or radius of curvature. By sliding the crown 96 alongthe indentation 152, the crown 96 is guided into the passage 132. Whenthe cartridge 62 contacts the stop 141 or comes close to contacting thestop 141, the clip 134 is removed from the anastomosis tool 64, and theassembly 94 is moved to its final position relative to the anastomosistool 64. The tool 64 is then ready for use.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. For example, the tools and functional package described abovemay be used for surgical procedures other than CABG procedures, such asperipheral vascular surgery, neurovascular surgery, or transplantsurgery. It is to be understood that the invention is not limited to thedetails of construction and/or the arrangements of components set forthin the above description or illustrated in the drawings. Therefore, theinvention is not to be restricted or limited except in accordance withthe following claims and their legal equivalents.

1. A system for preparing a graft vessel for anastomosis, comprising: afunctional package comprising a tray in which at least one recess isdefined; and an assembly held in at least one said recess, said assemblycomprising a crown and an anastomosis device connected to said crown;wherein at least one said recess is configured to hold a biocompatiblefluid.
 2. The system of claim 1, further comprising a pull-through toolconfigured to be held in said crown.
 3. The system of claim 2, whereinsaid pull-through tool comprises a tube, wherein at least a portion ofsaid tube is held within said crown.
 4. The system of claim 1, furthercomprising a stop clip detachably connected to said recess in which saidpull-through tool is held.
 5. The system of claim 4, wherein saidpull-through tool comprises a tube, and wherein said stop clip comprisesa guide defined therein, said guide configured to control the motion ofsaid tube.
 6. The system of claim 1, further comprising a poke-throughtool held in at least one said recess.
 7. The system of claim 6, whereina slot is defined in said recess in which said pull-through tool isheld, said slot shaped to receive said poke-through tool and control themotion of said poke-through tool relative to said crown.
 8. The systemof claim 7, wherein said slot is aligned with the axis of said crown. 9.The system of claim 1, further comprising an eversion shield held onsaid crown, said eversion shield covering said anastomosis device. 10.The system of claim 9, further comprising a poke-through tool configuredto engage said eversion shield and remove it from said crown and saidanastomosis device.
 11. The system of claim 1, wherein said recess inwhich said assembly is held is configured to hold an amount ofbiocompatible fluid sufficient to cover said crown.
 12. The system ofclaim 1, further comprising an anastomosis tool held in at least onesaid recess, said anastomosis tool comprising a passage configured toreceive said crown.
 13. The system of claim 12, further comprising aclip detachably connected to said anastomosis tool, wherein said clipguides said crown into said passage.
 14. The system of claim 1, whereinone said recess is a graft vessel storage recess.
 15. The system ofclaim 1, wherein one said recess is a stabilizing recess.
 16. Afunctional package for use in preparing a graft vessel for anastomosis,where that anastomosis is performed by a tool that deploys ananastomosis device; comprising: a tray in which at least one recess isdefined, wherein at least part of the tool is held in at least one saidrecess; wherein at least one said recess is shaped and sized to hold asufficient amount of biocompatible liquid to immerse at least part ofthe tool.
 17. A system for use in preparing a graft vessel foranastomosis, comprising: a tray in which at least one recess is defined;an anastomosis device; an anastomosis tool connected to and configuredto deploy said anastomosis device, wherein at least part of saidanastomosis tool is held in at least one said recess; and a quantity ofbiocompatible liquid within at least one said recess, said quantity ofbiocompatible liquid sufficient to immerse said anastomosis device. 18.The system of claim 17, wherein said biocompatible liquid is salinesolution.
 19. The system of claim 17, further comprising a pull-throughtool held by said anastomosis tool.
 20. The system of claim 17, furthercomprising a poke-through tool held in at least one said recess.